Abstract

This document contains the working procedure used in method validation for the validation of alternative (proprietary) methods against a reference method. Amendment 1 includes a revision of the introduction, the data evaluation of the qualitative method comparison test and the calculation of the relative detection limit. It also adds a new annex on the testing of methods for sterilization.

Begin

2021-06-28

WI

00463098

Planned document number

DIN EN ISO 16140-2/A1

Project number

05702537

Responsible national committee

NA 057-01-06 AA - Microbiology of the food chain  

Responsible european committee

CEN/TC 463 - Microbiology of the food chain  

Responsible international committee

ISO/TC 34/SC 9/WG 3 - Method validation  

draft standard

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method - AMENDMENT 1: Revision of qualitative MCS data evaluation, RLOD calculations in the ILS, calculation and interpretation of the RT study, and inclusion of a commercial sterility testing protocol for specific products (ISO 16140-2:2016/DAM 1:2023); German and English version EN ISO 16140-2:2016/prA1:2023
2023-08
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previous edition(s)

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO 16140-2:2016); German version EN ISO 16140-2:2016
2016-11

Order from DIN Media